FDA.report

Dymaxeon

Primary DI
00815500023530
Brand
Dymaxeon
Company
BACK 2 BASIC DIRECT, LLC
Model
05.5
Catalog number
09.0643
Device description
DYMAXEON T-HANDLE - QUICK CONNECT
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815500023530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815500023530008155000235308155000235300815500023530

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
2164475025info@back2basicsdirect.com

Regulatory Flags

DUNS number
043841348
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00815500023295Dymaxeon5.506.6340B-12020-03-06
00815500023301Dymaxeon5.506.6341B-12020-03-06
00815500023318Dymaxeon5.506.6540B-12020-03-06
00815500023325Dymaxeon5.506.6541B-12020-03-06
00815500023691Dymaxeon5.546.0725-042020-03-06
00815500023479Dymaxeon05.509.06752019-03-12
00815500025374Dymaxeon05.546.42402019-03-07
00815500025381Dymaxeon05.546.42412019-03-07
00815500025398Dymaxeon05.546.42422019-03-07
00815500025404Dymaxeon05.546.42432019-03-07
00815500025411Dymaxeon05.546.42442019-03-07
00815500025428Dymaxeon05.546.42452019-03-12
00815500025435Dymaxeon05.546.42462019-03-12
00815500025442Dymaxeon05.546.42472019-03-12
00815500020010Dymaxeon®05.506.1201B2016-01-19
00815500020027Dymaxeon®05.506.1202B2016-01-19
00815500023585Dymaxeon06.009.07112019-03-07
00815500023592Dymaxeon06.009.07122019-03-07
00815500023608Dymaxeon06.009.07132019-03-07
00815500025572Dymaxeon06.009.06732019-03-25

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